|- candidate number||6696|
|- NTR Number||NTR2094|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-nov-2009|
|- Secondary IDs|| 2009-017060-17 EudraCT number|
|- Public Title||The influence of statin therapy on DDAVP response in patients with Type 1 von Willebrand disease or mild Hemophilia A.|
|- Scientific Title||The STIMULATE study: Statins Influence on Minrin Upregulation of von Willebrand factor and factor VIII.|
|- hypothesis||Statin therapy increases DDAVP stimulated release of von Willebrand factor and factor VIII in patients with mild Hemophilia A and type 1 von Willebrand disease.|
|- Healt Condition(s) or Problem(s) studied||, Von Willebrand Disease, Hemophily A|
|- Inclusion criteria||1. Mild hemophilia A, or; |
2. Type 1 von Willebrand disease;
3. DDAVP response has been tested at least once before;
4. Age: 18 – 60 years;
6. Written informed consent is given.
|- Exclusion criteria||1. Moderate/Severe hemophilia A;|
2. Type 2 or 3 von Willebrand diseas;
3. Clinical history of any other hemostatic or thrombotic disorder;
4. Allergy or contra-indication for Simvastatine or Minrin therapy;
5. Medical indication for statin therapy;
6. Co-enrolment in other clinical study in the last 3 months;
7. No previous DDAVP-test;
8. First relative (brother/sister) participating in this study.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jan-2010|
|- planned closingdate||1-jul-2010|
|- Target number of participants||20|
|- Interventions||Two DDAVP infusions will be performed. The first DDAVP test will take place prior to starting statin therapy and the second test will be performed after 6 weeks of statin therapy. During both tests blood samples will be taken until 32 hours after DDAVP infusion (in total 7 times per test). In each bloodsample e.g. vWF activity and F VIII activity will be determined.|
|- Primary outcome||1. Von Willebrand factor antigen, von Willebrand factor activity and von Willebrand Factor propeptide plasma levels after DDAVP stimulation, during statin therapy;|
2. Factor VIII activity and factor VIII antigen plasma levels after DDAVP stimulation, during statin therapy.
|- Secondary outcome||Von Willebrand factor multimers, ADAMTS13 and tPA plasmalevels after DDAVP stimulation during statin therapy.|
|- Timepoints||1. Prior to starting statin therapy; |
2. After 6 weeks of statin therapy.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||M.D. C.L. Eckhardt|
|- CONTACT for SCIENTIFIC QUERIES||M.D. C.L. Eckhardt|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Background: |
Currently, in Hemophilia A and von Willebrand patients treatment with desmopressin (DDAVP) is the most feasible and patient friendly method of treatment. In patients with a limited response to DDAVP, optimalisation of DDAVP treatment is all the more important. There is evidence that statin therapy might upregulate Kruppel-like factor 2 and thereby enhance Weibel Palade Body exocytosis. Although statin therapy has many pleitropic effects next to its lipid lowering effects, the exact mechanism by which statin therapy might influence the endothelium remains unclear. Literature on this topic is scarce and conflicting. A better insight in the influence of statin therapy on DDAVP-mediated von Willebrand Factor and Factor VIII release might open ways to improve DDAVP treatment in these patient groups.
The aim of this study is to investigate the influence of statin therapy on DDAVP mediated release of von Willebrand Factor and Factor VIII.
Study design and population:
We will perform an experimental study consisting of patients with mild Hemophilia A and patients with von Willebrand disease type 1. The total duration of the study is 6 weeks. In this period a DDAVP test will be performed prior to starting statin therapy and after 6 weeks of statin therapy.
|- Main changes (audit trail)|
|- RECORD||5-nov-2009 - 5-jan-2010|